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Conditions
Interventions
to evaluate the efficacy and safety of 25 microgram of estradiol gel on the vaginal tissue of postmenopausal women.,to evaluate the efficacy and safety of KY jelly on the vaginal tissue of postmenopau
Active Comparator Drug,Placebo Comparator Drug
Estradiol vaginal gel,KY jelly
Sponsors
a research grant from the Faculty of Medicine Siriraj Hospital, Mahidol University
Eligibility
Sex/Gender
Female
Age
45 Years to No maximum
Inclusion criteria
Inclusion criteria: -Aged 45 years or older -Natural menopause/surgical menopause -Symptom of vaginal atrophy -TVS reveal endometrial thickness less than 5 mm -Normal cervical cytology within 3 years
Exclusion criteria
Exclusion criteria: -Known or suspected histories of breast cancer, cardiovascular disease, liver disease, gallbladder disease -Genital tract infection -Abnormal uterine bleeding with unknown cause -Thromboembolism -Previous hormonal used within 90 days -Hypersensitivity to study medication -All contraindications for administration of estrogen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective was the mean change from baseline to week 4 and 8 in vaginal maturation value 8 weeks Vaginal maturation value | — |
Secondary
| Measure | Time frame |
|---|---|
| the change of VMI, MBS, vaginal pH, VHI, FSFI, serum estradiol level, endometrium thickness 8 weeks VMI, MBS, vaginal pH, VHI, FSFI, serum estradiol level, endometrial thickness | — |
Countries
thailand
Contacts
Public ContactTitima Jirasawas
Unaffiliated.
Outcome results
None listed